Hologic, Inc. recalled 3,728 units of ThinPrep CytoLyt Solution on December 12, 2025. The recall follows the discovery of fungal contamination with Parengyodontium album. Patients and healthcare providers must stop using the affected products immediately.
Fungal contamination of affected lot with Parengyodontium album.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Hologic, Inc or your healthcare provider for instructions. Notification method: Letter
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ThinPrep CytoLyt Solution is a buffered cell wash solution used in medical procedures for the preparation of specimens. Healthcare providers rely on this product for accurate cytological analysis.
The presence of Parengyodontium album in the solution can lead to contamination, posing a risk of infection to patients during medical procedures.
This recall is not part of a broader industry pattern.
The recall impacts healthcare operations, potentially delaying procedures and requiring the immediate stoppage of use of the affected solution.
The catalog number and lot number can typically be found on the product label or packaging.
Expect a processing time of 4-6 weeks for refunds or replacements after contacting the manufacturer.
Keep copies of any correspondence, receipts, and photographs of the product as evidence.
The recalled product is ThinPrep CytoLyt Solution, catalog number 0236004, with lot number 5062EC. It is distributed nationwide across the United States. Specific identifiers include UDI: (01)25420045508405(17)270303(10)5062EC.
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